A Study of TACE Combined With Atezolizumab Plus Bevacizumab or TACE Alone in Patients With Untreated Heaptocellular Carcionma

NCT ID: NCT04712643

Last Updated: 2025-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

342 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-12

Study Completion Date

2029-02-01

Brief Summary

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This study will evaluate the efficacy and safety of atezolizumab plus bevacizumab combined with on-demand TACE compared to on-demand TACE alone in participants with hepatocellular carcinoma who are at high risk of poorer outcome following TACE treatment.

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A: atezolizumab + bevacizumab + TACE

Participants will receive atezolizumab plus bevacizumab on Day 1 of a 21-Day cycle, after every on-demand transarterial chemoembolization procedure.

Group Type EXPERIMENTAL

Atezolizumab

Intervention Type DRUG

Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until participant experience loss of clinical benefit as evaluated by the investigator or unacceptable toxicity or withdrawal of informed consent.

Becavizumab

Intervention Type DRUG

Bevacizumab will be administered by IV infusion at a fixed dose of 15 mg/kg on Day 1 of each 21-day Cycle.

Transarterial chemoembolization (TACE)

Intervention Type DEVICE

TACE will be performed by clinical demand.

Arm B: TACE alone

Participants will receive on-demand transarterial chemoembolization.

Group Type ACTIVE_COMPARATOR

Transarterial chemoembolization (TACE)

Intervention Type DEVICE

TACE will be performed by clinical demand.

Interventions

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Atezolizumab

Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until participant experience loss of clinical benefit as evaluated by the investigator or unacceptable toxicity or withdrawal of informed consent.

Intervention Type DRUG

Becavizumab

Bevacizumab will be administered by IV infusion at a fixed dose of 15 mg/kg on Day 1 of each 21-day Cycle.

Intervention Type DRUG

Transarterial chemoembolization (TACE)

TACE will be performed by clinical demand.

Intervention Type DEVICE

Other Intervention Names

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Tecentriq Avastin

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of HCC by histology/ cytology or clinical criteria
* Eligible for TACE treatment
* No prior systemic therapy for HCC, especially immunotherapy
* No prior locoregional therapy to the target lesion(s)
* At least one measurable untreated lesion
* ECOG Performance Status of 0-1
* Child-Pugh class A

Exclusion Criteria

* Evidence of Vp3/4 and hepatic vein tumor thrombus (HVTT)
* Evidence of extrahepatic spread (EHS)
* Being a candidate for curative treatments
* Any condition representing a contraindication to TACE as determined by the investigators
* Active or history of autoimmune disease or immune deficiency
* Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk for bleeding
* A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
* Evidence of bleeding diathesis or significant coagulopathy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Anhui Provincial Hospital

Anhui, , China

Site Status

Peking University First Hospital

Beijing, , China

Site Status

Peking University People's Hospital

Beijing, , China

Site Status

Beijing You An Hospital

Beijing, , China

Site Status

Beijing Tsinghua Changgung Hospital

Beijing, , China

Site Status

Hunan Cancer Hospital

Changsha, , China

Site Status

West China Hospital, Sichuan University

Chengdu, , China

Site Status

The First Affiliated Hospital, Chongqing Medical University

Chongqing, , China

Site Status

Southwest Hospital , Third Military Medical University

Chongqing, , China

Site Status

The 900th Hospital of PLA joint service support force

Fuzhou, , China

Site Status

The First Affiliated Hospital Of Fujian Medical University

Fuzhou, , China

Site Status

Fujian Cancer Hospital

Fuzhou, , China

Site Status

Mengchao Hepatobiliary Hospital Of Fujian Medical University

Fuzhou, , China

Site Status

Sun Yet-sen University Cancer Center

Guangzhou, , China

Site Status

Nanfang Hospital, Southern Medical University

Guangzhou, , China

Site Status

Zhejiang Cancer Hospital

Hangzhou, , China

Site Status

Harbin Medical University Cancer Hospital

Harbin, , China

Site Status

Jiangsu Cancer Hospital

Nanjing, , China

Site Status

Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

Nanjing, , China

Site Status

Guangxi Cancer Hospital of Guangxi Medical University

Nanning, , China

Site Status

The First Affiliate Hospital of Guangxi Medical University

Nanning, , China

Site Status

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status

Renji Hospital Shanghai Jiaotong University School of Medicine

Shanghai, , China

Site Status

Zhongshan Hospital Fudan Unvierstiy

Shanghai, , China

Site Status

Shengjing Hospital of China Medical University

Shenyang, , China

Site Status

Tianjin Cancer Hospital

Tianjin, , China

Site Status

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, , China

Site Status

Xi'an Inernational Medical Center Hospital

Xi'an, , China

Site Status

Henan Cancer Hospital

Zhengzhou, , China

Site Status

Zhuhai People's Hospital

Zhuhai, , China

Site Status

Aichi Cancer Center

Aichi, , Japan

Site Status

Chiba University Hospital

Chiba, , Japan

Site Status

Kurume University Hospital

Fukuoka, , Japan

Site Status

Hiroshima University Hospital

Hiroshima, , Japan

Site Status

Yokohama City University Medical Center

Kanagawa, , Japan

Site Status

Kanagawa Cancer Center

Kanagawa, , Japan

Site Status

Kitasato University Hospital

Kanagawa, , Japan

Site Status

The University of Osaka Hospital

Osaka, , Japan

Site Status

Kindai University Hospital

Osaka, , Japan

Site Status

Toranomon Hospital

Tokyo, , Japan

Site Status

Countries

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China Japan

Other Identifiers

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ML42612

Identifier Type: -

Identifier Source: org_study_id

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